Major Depressive DisorderNCT06897670
Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Mild Cognitive Impairment
- What is being tested?
- Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Potential participants will be identified from the Mayo Clinic outpatient clinics in the Departments of Psychiatry, Psychology, Neurology, and Primary Care.
Who may be able to join
- General Inclusion Criteria (across all diagnostic groups):
- 18 years and older
- Ability to provide written informed consent
- Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures
- Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)
- Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention
Show all 17Show fewer
- Specific Inclusion Criteria (for diagnostic groups):
- Healthy control
- o No past or current psychiatric or cognitive disorder
- Major depressive disorder (MDD):
- Diagnosis of major depressive disorder, confirmed through clinical evaluation.
- No history of bipolar disorder or psychotic symptoms.
- Bipolar disorder:
- o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
- Mild Cognitive Impairment (MCI):
- Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
- No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.
Who cannot join
- General Exclusion Criteria (across all diagnostic groups):
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any severe or unstable medical condition that could interfere with participation or data collection
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results
- Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol
- Pregnant women will be excluded due to potential physiological changes that could affect study outcomes
Show all 17Show fewer
- Specific Exclusion Criteria (for diagnostic groups):
- Healthy control
- o Any past or current psychiatric or cognitive disorder
- Major depressive disorder (MDD):
- Diagnosis of bipolar disorder or schizophrenia.
- Brain stimulation therapy within the past 3 months.
- Bipolar disorder:
- o Diagnosis of schizophrenia or schizoaffective disorder.
- Mild Cognitive Impairment (MCI):
- Diagnosis of dementia.
- Significant cognitive impairment preventing understanding or completion of study tasks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sarah M. Williams, 507-422-2972
Maria I. Lapid, M.D.
About this study
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.
Read the detailed description
This study will examine cerebral hemodynamic patterns in individuals with mood disorders (major depressive disorder and bipolar disorder) and cognitive disorders (mild cognitive impairment) using functional near-infrared spectroscopy (fNIRS). The primary goal is to compare hemodynamic patterns between these groups, while the secondary goal is to explore correlations between these patterns and symptom severity based on standardized clinical assessments. Additionally, electrophysiological data, including photoplethysmography (PPG) and electrocardiogram (ECG), will be analyzed to investigate autonomic nervous system activity and its relationship with cerebral hemodynamics.
- Being tested
- Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
- Keywords
- functional near-infrared spectroscopy, diagnostics, mood disorders, mild cognitive impairment
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Cognitive Dysfunction, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.Other
Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex.
Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns.
- Resting-State Measurement: 5-10 min resting-state scans.
- Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min).
- During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG).
- Each participant will complete 3 sets of resting-state and task-based measurements.
Total estimated time for fNIRS assessment: 45-60 min.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | o No past or current psychiatric or cognitive disorder. Receives: Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. | |
| Major Depressive Disorder | * Diagnosis of major depressive disorder, confirmed through clinical evaluation.
* No history of bipolar disorder or psychotic symptoms. Receives: Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. | |
| Bipolar Disorder | o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation. Receives: Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. | |
| Mild Cognitive Impairment (MCI) | * Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
* No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia. Receives: Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oxyhemoglobin
Changes in oxyhemoglobin will be measured with a functional near-infrared spectroscopy (fNIRS) device by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Oxyhemoglobin results are reported as a percentage of oxygen-bound hemoglobin compared to the total hemoglobin in the blood.
Measured: Baseline, 60 minutes
Secondary outcomes (6)
Hamilton Depression Rating Scale (HAM-D)
A clinician-administered tool revaluating depression severity. The 17-item version assesses symptoms such as depressed mood, insomnia, and somatic complaints. Each item is scored on a 3- or 5-point scale, resulting in total scores that range from 0 to 52, with scores of 0-7 considered normal, 8-16 indicating mild depression, 17-23 moderate depression, and 24 or greater severe depression.
Measured: Baseline
Young Mania Rating Scale (YMRS)
A clinician-rated scale administered to measure the severity of manic symptoms in participants diagnosed with bipolar disorder (during manic or hypomanic episodes). It includes 11 items assessing areas such as elevated mood, irritability, and hyperactivity. Each item is scored on a scale of 0 to 4 or 0 to 8, with total scores ranging from 0 to 60. Severity thresholds include no significant symptoms (≤12), mild mania (13-20), moderate mania (21-35), and severe mania (>35).
Measured: Baseline
Clinical Global Impression-Bipolar (CGI-BP)
A clinician-rated measure that provides a global assessment of illness severity, improvement, and therapeutic response in individuals with bipolar disorder. It includes separate ratings for mania, depression, and overall illness on a 7-point scale, where 1 indicates "normal, not at all ill" and 7 indicates "among the most severely ill."
Measured: Baseline
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination is used to assess domains such as orientation, attention, memory, language, and visuospatial skills. It has a maximum score of 30, with lower scores indicating greater cognitive impairment. Scores are typically categorized as no cognitive impairment (24-30), mild cognitive impairment (18-23), and severe cognitive impairment (0-17).
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report questionnaire used to measure the severity of depressive symptoms over the past two weeks. This questionnaire is used in our clinical practice and will be collected from patient only if not already completed. It consists of nine items, each scored on a scale from 0 ("Not at all") to 3 ("Nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater symptom severity, categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe depression (20-27).
Measured: Baseline
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) is a standardized cognitive assessment tool designed to evaluate cognitive decline, particularly in Alzheimer's disease (AD) and mild cognitive impairment (MCI). It includes measures of verbal fluency, word list learning, delayed recall, recognition memory, constructional praxis, and global cognition. The battery incorporates a 15-item abbreviation of the Boston Naming Task (J2) and a slightly modified version of the MMSE that does not use serial 7s (J3).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start26 Mar 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Lapid, M.D., Mayo Clinic
- Investigators
- Maria I. Lapid, M.D., Principal investigator, Mayo ClinicPaul H. Min, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897670
- Sponsor's protocol ID
- 24-012395
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yucel MA, Selb JJ, Huppert TJ, Franceschini MA, Boas DA. Functional Near Infrared Spectroscopy: Enabling Routine Functional Brain Imaging. Curr Opin Biomed Eng. 2017 Dec;4:78-86. doi: 10.1016/j.cobme.2017.09.011. Epub 2017 Oct 6.
PubMed 29457144Piper SK, Krueger A, Koch SP, Mehnert J, Habermehl C, Steinbrink J, Obrig H, Schmitz CH. A wearable multi-channel fNIRS system for brain imaging in freely moving subjects. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):64-71. doi: 10.1016/j.neuroimage.2013.06.062. Epub 2013 Jun 28.
PubMed 23810973Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PubMed 14399272Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
PubMed 728692Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W. Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997 Dec 5;73(3):159-71. doi: 10.1016/s0165-1781(97)00123-6.
PubMed 9481807Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
PubMed 2771064
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
- ClinicalTrials.gov ID
- NCT06897670
- Acronym / sponsor ID
- 24-012395
- Keywords
- functional near-infrared spectroscopy, diagnostics, mood disorders, mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.
Detailed description
This study will examine cerebral hemodynamic patterns in individuals with mood disorders (major depressive disorder and bipolar disorder) and cognitive disorders (mild cognitive impairment) using functional near-infrared spectroscopy (fNIRS). The primary goal is to compare hemodynamic patterns between these groups, while the secondary goal is to explore correlations between these patterns and symptom severity based on standardized clinical assessments. Additionally, electrophysiological data, including photoplethysmography (PPG) and electrocardiogram (ECG), will be analyzed to investigate autonomic nervous system activity and its relationship with cerebral hemodynamics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.o No past or current psychiatric or cognitive disorder. |
| Major Depressive Disorder | – | Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.* Diagnosis of major depressive disorder, confirmed through clinical evaluation. * No history of bipolar disorder or psychotic symptoms. |
| Bipolar Disorder | – | Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation. |
| Mild Cognitive Impairment (MCI) | – | Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.* Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data. * No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified from the Mayo Clinic outpatient clinics in the Departments of Psychiatry, Psychology, Neurology, and Primary Care.
Key inclusion criteria (17 listed)
- 18 years and older
- Ability to provide written informed consent
- Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures
- Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)
- Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention
Key exclusion criteria (17 listed)
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any severe or unstable medical condition that could interfere with participation or data collection
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results
- Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol
- Pregnant women will be excluded due to potential physiological changes that could affect study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns. * Resting-State Measurement: 5-10 min resting-state scans. * Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min). * During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG). * Each participant will complete 3 sets of resting-state and task-based measurements. Total estimated time for fNIRS assessment: 45-60 min. | Other | Bipolar Disorder, Healthy Controls, Major Depressive Disorder, Mild Cognitive Impairment (MCI) |
Primary outcome
Changes in oxyhemoglobin
Time frame: Baseline, 60 minutes
Changes in oxyhemoglobin will be measured with a functional near-infrared spectroscopy (fNIRS) device by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Oxyhemoglobin results are reported as a percentage of oxygen-bound hemoglobin compared to the total hemoglobin in the blood.
6 secondary outcomes
Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline
Young Mania Rating Scale (YMRS)
Time frame: Baseline
Clinical Global Impression-Bipolar (CGI-BP)
Time frame: Baseline
Mini-Mental State Examination (MMSE)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29457144Yucel MA, Selb JJ, Huppert TJ, Franceschini MA, Boas DA. Functional Near Infrared Spectroscopy: Enabling Routine Functional Brain Imaging. Curr Opin Biomed Eng. 2017 Dec;4:78-86. doi: 10.1016/j.cobme.2017.09.011. Epub 2017 Oct 6.
- Background: PubMed 23810973Piper SK, Krueger A, Koch SP, Mehnert J, Habermehl C, Steinbrink J, Obrig H, Schmitz CH. A wearable multi-channel fNIRS system for brain imaging in freely moving subjects. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):64-71. doi: 10.1016/j.neuroimage.2013.06.062. Epub 2013 Jun 28.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 14399272HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Background: PubMed 728692Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
- Background: PubMed 9481807Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W. Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997 Dec 5;73(3):159-71. doi: 10.1016/s0165-1781(97)00123-6.
- Background: PubMed 2771064Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria I. Lapid, M.D. principal investigator
Mayo Clinic
Paul H. Min, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah M. Williams (507-422-2972, Williams.Sarah2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in oxyhemoglobin (time frame: Baseline, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897670, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.